The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes
NCT ID: NCT05901259
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2024-08-01
2027-12-31
Brief Summary
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Detailed Description
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The subjects will serve as their own control and the data will be collected before, during and after the treatment period. As the electrical stimulation from the suit usually is above the level of sensation, the study participant cannot be blinded to the treatment.
To prevent bias, multiple investigators will be collecting the data and only standardized and validated methods will be used. All investigators will be trained on the measurements prior to the registry start.
Additionally, all investigators are trained and certified in the Exopulse method, and the generic stimulation settings are selected according to a standardized matrix based on the subjects' age and level of impairment.
Re-assessments during scheduled visits are part of normal routine and use. The decision whether the subjects will be enrolled in the registry is separated from the subject's decision to use the device.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Interventions
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Exopulse Mollii Suit
The registry is designed to demonstrate the impact of Exopulse Mollii Suit on improvement of muscle relaxation, muscle activation, local blood circulation and/or chronic pain relief. The subjects included use the suit for 60 minutes every other day, unless other is specified by the Investigator, in their home environment for up to a maximum of 12 consecutive weeks. Qualitative and quantitative measures will be collected at baseline (T0), after 60 minutes stimulation (T1), after 4 weeks (T4) and at the end of the 12-week intervention period (T12).
Eligibility Criteria
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Inclusion Criteria
* Diagnosed \>6 months prior to inclusion in case of MS, stroke, or SCI
* Give written informed consent
* Cognitively able to understand and follow verbal and/or written instructions
* A minimum age of 2 years
Exclusion Criteria
* Being introduced to any new medication affecting the neuromuscular activity during the study period
* Using botulinum toxin \<3 month before or during the study period
* Subjects \<100 cm and \<13 kg
* Subjects \>205 cm and \>115 kg
2 Years
ALL
No
Sponsors
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Exoneural Network AB
INDUSTRY
Responsible Party
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Principal Investigators
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Mimi Westerlund, Phd
Role: PRINCIPAL_INVESTIGATOR
Exoneural Network AB
Locations
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Exoneural Network Ab
Bergshamra, Stockholm County, Sweden
Countries
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Central Contacts
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Other Identifiers
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CIV-22-08-040366
Identifier Type: -
Identifier Source: org_study_id
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